Tesamorelin
Yes, tesamorelin is FDA-approved, for one use only: reducing excess abdominal fat in HIV-infected adults with lipodystrophy. It was first approved as Egrifta on 10 November 2010 and is sold today as Egrifta SV and Egrifta WR. It is a synthetic GHRH analog that makes the pituitary release more growth hormone, which lowers visceral fat without changing body weight.
Is tesamorelin FDA-approved, and for what?
Yes, for one indication. The FDA first approved tesamorelin as Egrifta on 10 November 2010.7 The approved use is “the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy”. The original label, Egrifta SV and Egrifta WR all carry this one indication.1,8,9 No other use is on the label: not weight loss, not growth hormone deficiency, and not anti-aging or body composition in people without HIV.
Three formulations have been approved under the same license (BLA 022505). They differ in vial strength, labeled dose and how the drug is mixed. The labeled doses are not interchangeable: the Egrifta WR label says it and Egrifta SV “are not substitutable”.9
| Product | Vial | Labeled dose | Mixing | FDA timeline |
|---|---|---|---|---|
| Egrifta | 1 mg | 2 mg SubQ once daily, abdomen8 | Discard if not used immediately8 | Original approval 10 Nov 20107 |
| Egrifta SV | 2 mg, single-dose | 1.4 mg (0.35 mL) SubQ once daily, abdomen1 | 0.5 mL sterile water; inject right away and discard the rest1 | Dosing section changed 11/2018; label revised 07/20191 |
| Egrifta WR | 11.6 mg | 1.28 mg (0.16 mL) SubQ once daily, abdomen9 | 1.3 mL bacteriostatic water; one vial gives 7 daily doses, discard 7 days after mixing9 | Approved 25 Mar 20257,10 |
The current package inserts are on Drugs@FDA and DailyMed, linked in the Research list below.1,2,9
What the label says it does not do
The Limitations of Use section of the current label makes three points.9 Long-term cardiovascular safety has not been established, so prescribers should weigh whether to continue in patients whose visceral fat has not come down. It is not indicated for weight loss, because its effect on weight is neutral. And there are no data that it improves adherence to antiretroviral therapy.
The approval rests on two 26-week phase 3 trials (412 and 404 patients) that used 2 mg a day. Visceral fat on CT fell by 18% and 14% on tesamorelin, compared with +2% and −2% on placebo. Body weight barely moved: −0.4 kg and +0.5 kg on tesamorelin, against 0.0 kg and +0.3 kg on placebo.8
Monitoring is built into the label. Check glucose before and during treatment. Monitor IGF-1, and consider stopping if it stays elevated (the label gives >3 SDS as an example). Contraindications are hypothalamic-pituitary axis disruption, active malignancy, hypersensitivity to tesamorelin or its excipients, and pregnancy.9
Tesamorelin reconstitution calculator
Tesamorelin dilution chart & full calculator →Typical dosing
| Goal | Range | Route | Frequency |
|---|---|---|---|
| Egrifta WR (11.6 mg vial, current label) | 1.28 mg (0.16 mL) | SubQ, abdomen (rotate sites) | once daily; one vial lasts 7 days |
| Egrifta SV (2 mg vial) | 1.4 mg (0.35 mL) | SubQ, abdomen (rotate sites) | once daily; mix fresh each day |
| Egrifta (original 1 mg vials, 2010 label) | 2 mg | SubQ, abdomen | once daily |
Ranges compiled from research literature — not a prescription.
How it works
Tesamorelin is a 44-amino-acid analog of native GHRH, modified with an N-terminal trans-3-hexenoic acid group that resists enzymatic (DPP-4) degradation and extends its activity relative to endogenous GHRH. It binds GHRH receptors on pituitary somatotroph cells, a Gs-coupled pathway that raises cAMP and triggers calcium-dependent, pulsatile release of growth hormone — mirroring the body's natural GH secretion pattern rather than delivering GH directly.
The downstream GH pulses raise circulating IGF-1 and, in HIV-infected patients with abdominal fat accumulation, produce a measurable reduction in visceral adipose tissue (VAT). This is the basis of the only approved indication: a pooled analysis of two 26-week phase 3 trials (n=806) reported meaningful VAT reduction with tesamorelin 2 mg/day versus placebo, and a separate randomized trial (Stanley et al., JAMA 2014) found tesamorelin reduced VAT by roughly 9.9% versus a 6.6% increase with placebo, along with modest reductions in liver fat, without worsening glucose or lipid parameters in that population.
It is important to be precise about scope: the FDA approval and this trial evidence are specific to HIV-associated lipodystrophy — a distinct metabolic condition tied to antiretroviral therapy and HIV infection itself. Use of tesamorelin for general anti-aging, bodybuilding, or fat loss in people without HIV lipodystrophy is off-label and has not been evaluated in the same rigorous, FDA-reviewed trials; efficacy and safety in that population are not established by the approved label.
Because tesamorelin acts upstream (on the pituitary) rather than supplying GH directly, its effects depend on an intact hypothalamic-pituitary axis — which is also why pituitary axis disruption is a contraindication, and why its GH/IGF-1 stimulating effect carries the same theoretical long-term considerations (e.g., malignancy risk, IGF-1-related effects) associated with other GH-axis therapies.
Side effects & safety
- Fluid retention is common and can present as edema, arthralgia, myalgia, or carpal tunnel syndrome, especially early in treatment.
- Because tesamorelin raises IGF-1, the FDA label calls for monitoring IGF-1 levels during therapy and considering discontinuation with persistent elevation, given unknown long-term effects of sustained elevation.
- Glucose intolerance can occur; the label recommends evaluating glucose before and during treatment, with added caution in patients with diabetes or prediabetes.
- Contraindicated in active malignancy — pre-existing malignancy must be inactive and treatment complete before starting.
- Contraindicated in pregnancy and in patients with disruption of the hypothalamic-pituitary axis (pituitary surgery, radiation, tumor) or hypersensitivity to tesamorelin/excipients.
- Injection-site reactions and paresthesias are among the most common adverse effects; this profile and all dosing above reflect the FDA-approved use only — it does not extend to unapproved (off-label) uses.
Research
Primary sources — PubMed.
- FDA. EGRIFTA SV (tesamorelin for injection) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
- DailyMed. EGRIFTA SV label. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
- Falutz J, et al. Effects of tesamorelin on visceral fat: pooled analysis of two phase 3 trials. J Clin Endocrinol Metab. 2010. https://academic.oup.com/jcem/article-abstract/95/9/4291/2835394
- Stanley TL, et al. Effect of Tesamorelin on Visceral Fat and Liver Fat in HIV-Infected Patients. JAMA. 2014. https://pmc.ncbi.nlm.nih.gov/articles/PMC4363137/
- Tesamorelin. LiverTox, NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK548730/
- ClinicalTrials.gov. TH9507 in Patients With HIV-Associated Lipodystrophy. NCT00123253. https://clinicaltrials.gov/study/NCT00123253
- FDA, Drugs@FDA. EGRIFTA (tesamorelin acetate), BLA 022505: product and approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
- FDA. EGRIFTA (tesamorelin for injection) Prescribing Information, 11/2010 (original approval label). https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf
- FDA. EGRIFTA WR (tesamorelin) for injection Prescribing Information, revised 3/2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf
- Theratechnologies Inc. Material change report: FDA approval of the sBLA for the F8 formulation of tesamorelin (EGRIFTA WR), 25 March 2025 (SEC Form 6-K, Exhibit 99.1). https://www.sec.gov/Archives/edgar/data/1512717/000119312525070184/d938025dex991.htm